ISO 18250-6:2019 医療機器—ヘルスケアアプリケーション用のリザーバーデリバリーシステム用コネクタ—パート6：ニューラルアプリケーション | ページ 2

Foreword

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The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives ).

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This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices.

A list of all parts in the ISO 18250 series can be found on the ISO website.

In this document, the following print types are used:

• requirements and definitions: roman type;
• informative material appearing outside of tables, such as notes, examples and references: smaller type;
• terms defined in this document: small caps;
• compliance requirements: italic type.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

The verbal forms used in this document conform to usage described in the ISO/IEC Directives, Part 2, Annex H. For the purposes of this document, the auxiliary verb:

• “shall” means that compliance with a requirement or a test is mandatory for compliance with this document;
• “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this document;
• “may” is used to describe a permissible way to achieve compliance with a requirement or test;
• An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.

Introduction

During the development of the ISO 80369 series of standards for small-bore connectors for liquids and gases in healthcare applications it became evident that the risk of misconnections was not limited to the patient access connectors and that the connectors used at the reservoir end of the systems were also a potential high risk for misconnection. For many reasons these reservoir connectors did not fit well within the scope of ISO 80369 so it was decided to develop a separate series of standards specifically for these reservoir connectors. The 18250 series takes into account the risks of misconnections between the reservoir connectors of different applications including the existing standardized IV spike specified in ISO 8536-4 and ISO 1135-4.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 18250-1 and ISO 80369-6 apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography